Commissioning & Qualification (C&Q) Engineer
- Dublin
- Contract
- Full-time
- Develop and execute commissioning protocols (FAT, SAT, IV, FT) for GMP-regulated systems.
- Perform system startup, debugging, and initial testing of facility, process, and utility systems.
- Ensure systems are installed and operating per design specifications.
- Collaborate with cross-functional teams (Engineering, Manufacturing, Quality) during equipment installation and commissioning.
- Review and verify technical documentation (P&IDs, wiring diagrams, datasheets).
- Conduct risk assessments and develop test plans for facility and utility systems.
- Ensure compliance with GAMP, ISPE guidelines, and regulatory requirements (FDA, EMA).
- Redline engineering drawings and participate in system walkdowns.
- Prepare and execute C&Q documentation and summary reports.
- Support continuous improvement initiatives related to C&Q processes.
- Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biopharmaceutical, or related field).
- Minimum 5 years of experience in C&Q within the Life Sciences industry.
- Strong knowledge of regulatory guidelines (FDA, EMA, ISPE, GAMP).
- Hands-on experience with risk-based qualification and C&Q protocols.
- Experience with HVAC systems, black/clean utilities, filling lines, component prep, and temperature-controlled equipment.
- Proficient in reviewing/redlining engineering documents.
- Familiarity with Data Integrity and Computer System Validation (CSV).
- Experience with digital execution tools (e.g., Kneat, EDMS).
- Strong problem-solving, communication, and teamwork skills.
- Experience working on large-scale capital projects is a plus.